Implementing and monitoring the right to health in breast cancer: selection of indicators using a Delphi process

Background Women with breast cancer have different chances of surviving their disease, depending on where they live. Variations in survival may stem from unequal access to prompt diagnosis, treatment and care. Implementation of the right to health may help remedy such inequalities. The right to health is enshrined in international human rights law, notably Article 12 of the International Covenant on Economic, Social and Cultural Rights. A human rights-based approach to health requires a robust, just and efficient health system, with access to adequate health services and medicines on a non-discriminatory basis. However, it may prove challenging for health policymakers and cancer management specialists to implement and monitor this right in national health systems. Method This article presents the results of a Delphi study designed to select indicators of implementation of the right to health to inform breast cancer care and management. In a systematic process, 13 experts examined an initial list of 151 indicators. Results After two rounds, 54 indicators were selected by consensus, three were rejected, three were added, and 97 remained open for debate. For breast cancer, right-to-health features selected as worth implementing and monitoring included the formal recognition of the right to health in breast cancer strategies; a population-based screening programme, prompt diagnosis, strong referral systems and limited waiting times; the provision of palliative, survivorship and end-of-life care; the availability, accessibility, acceptability and quality (AAAQ) of breast cancer services and medicines; the provision of a system of accountability; and the collection of anonymised individual data to target patterns of discrimination. Conclusion We propose a set of indicators as a guide for health policy experts seeking to design national cancer plans that are based on a human rights-based approach to health, and for cancer specialists aiming to implement principles of the right to health in their practice. The 54 indicators selected may be used in High-Income Countries, or member states of the OECD who also have signed the International Covenant on Economic, Social and Cultural Rights to monitor progress towards implementation of the right to health for women with breast cancer. Supplementary Information The online version contains supplementary material available at 10.1186/s12939-023-01964-w.


Data sources
How it contributes to realising the right to health Principles of the right to health The screening programmes involves annual or biennial mammography in women aged 50-69 Ministry of Health websites Although there are debates in the scientific community about the optimal age range, the age group reported in this work is determined by international guidelines (ESMO).

Cost-effectiveness, core obligations
The screening programme includes annual MRI and annual mammography, concomitant or alternating, for women with a strong familial history of breast cancer Ministry of Health websites This is recommended by international guidelines (ESMO). This contributes to better equity under the right to health by ensuring women with increased risk have chances of getting an early diagnosis. This contributes to the AAAQ of services.
Cost-effectiveness, core obligations, availability, accessibility, acceptability and quality of diagnostic services The screening programme includes mobile units in hard-to-reach communities Ministry of Health websites This contributes to a better geographical reach of the screening programme and gives more accessible screening options to women living away from the main hospitals. This contributes to the non-discriminatory element of the right to health and AAAQ of services.
Cost-effectiveness, core obligations, availability, accessibility, acceptability and quality of diagnostic services, nondiscrimination There is genetic testing in place for women with strong familial history of breast cancer Ministry of Health websites This is recommended by international guidelines (ESMO). This contributes to better equity under the right to health by ensuring women with increased risk have chances of getting an early diagnosis. This contributes to the AAAQ of services.
Cost-effectiveness, core obligations, availability, accessibility, acceptability and quality of diagnostic services There is a referral system in place for women with strong familial history of breast cancer to have a mammogram or MRI Ministry of Health websites, national health system If and when breast cancer is suspected, a referral system allows the patient to access diagnostic services early. This contributes to AAAQ of services.
Cost-effectiveness, core obligations, availability, accessibility, acceptability and quality of diagnostic services There is a referral system in place from primary care to oncology services Ministry of Health websites, national health system If and when breast cancer is suspected, a referral system allows the patient to access diagnostic services early. This contributes to AAAQ of services.
Cost-effectiveness, core obligations, availability, accessibility, acceptability and quality of diagnostic services There is a specified maximum waiting time between diagnostic suspicion in primary care and the first appointment with an oncologist Ministry of Health websites, national health system This shows the state's commitment to early diagnosis of breast cancer. The earlier the cancer is diagnosed, the better chances of survival are.

Cost-effectiveness, core obligations
There is a specified maximum waiting time between the confirmed diagnostic and the first appointment for treatment National guidelines This shows the state's commitment to early treatment of breast cancer. The earlier the cancer is treated, the better chances of survival are.
Cost-effectiveness, core obligations The national diagnosis guidelines involve pathological evaluation in line with ESMO or ASCO recommendations National guidelines As above. ESMO recommendations: histology from the primary tumour and cytology/histology of the axillary nodes when involvement is suspected.
Cost-effectiveness, core obligations, quality of diagnostic services The national diagnosis guidelines involve genetic counselling and testing for germline BRCA1 and BRCA2 mutations in high-risk group breast cancer patients National guidelines As above, this is in line with international guidelines (ESMO) and allow women with higher risk to be diagnosed early. This contributes to better equity.
Cost-effectiveness, core obligations, quality of diagnostic services and non-discrimination The national treatment guidelines offer breast reconstruction to all women requiring mastectomy National guidelines Losing a breast after a mastectomy can be a traumatic event for a woman. Breast reconstruction allows the woman to recover her breast. This contributes to the acceptability and quality requirements under the right to health.

Acceptability and quality of health services
The number of mammography units, per 1,000,000 inhabitants OECD statistics health equipment; WHO Global Health Observatory medical equipment (per million women aged 50-69) This shows the availability of equipment that is necessary for early detection of breast cancer.

Availability of diagnostic equipment
Disaggregated by geography To our knowledge, no availability of data, or case-by-case basis This shows whether the equipment is evenly spread across the country or whether some regions are left behind. This shows the availability and accessibility requirements under the right to health, as well as nondiscrimination based on geography which may be a proxy for socio-economic status.
Availability and accessibility of diagnostic equipment, nondiscrimination

Building blocks and indicators
Data sources How it contributes to realising the right to health Principles of the right to health The number of ultrasound machines, per 1,000 inhabitants Statista for Italy; contact the OECD for international data This shows the availability of equipment that is necessary for early detection of breast cancer, especially in younger women with denser breast tissue.

Availability of diagnostic equipment
Disaggregated by geography To our knowledge, no availability of data, or case-by-case basis This shows whether the equipment is evenly spread across the country or whether some regions are left behind. This shows the availability and accessibility requirements under the right to health, as well as nondiscrimination based on geography which may be a proxy for socio-economic status.
Availability and accessibility of diagnostic equipment, nondiscrimination The number of radiotherapy units is at least as high as the optimal threshold set by the IAEA (one radiotherapy unit per 500,000 population) OECD / AGART report (expressed as the number of linear accelerators (LINACs) per million population) referring to the IAEA-DIRAC database 2007-13 This shows the availability of equipment that is necessary for treatment of breast cancer.

Availability of diagnostic equipment
Disaggregated by geography To our knowledge, no availability of data, or case-by-case basis This shows whether the equipment is evenly spread across the country or whether some regions are left behind. This shows the availability and accessibility requirements under the right to health, as well as nondiscrimination based on geography which may be a proxy for socio-economic status.
Availability and accessibility of diagnostic equipment, nondiscrimination Number of disciplines forming part of the breast cancer care unit in a given hospital Surveys ESMO recommends multidisciplinary teams to treat breast cancer as it results in better outcomes. This contributes to the acceptability and quality of services under the right to health.
Acceptability and quality of health services Disaggregated by geography Surveys Shows potential discrimination based on geography which may be a proxy for socio-economic status.

Non-discrimination
Number of specialists the breast cancer unit collaborates with, out of a psychologist, a social worker, a dietitian, an exercise physiologist, a genetic counsellor, an occupational therapist, a physiotherapist, and a specialist palliative care

Surveys
The disciplines listed in the indicator are recommended by the Australian optimal care pathway for breast cancer. ESMO recommends a physiotherapist, a psychologist and a geneticist. This contributes to the acceptability and quality of services under the right to health.

Acceptability and quality of health services
Indicator #29 disaggregated (novel) Disaggregated by geography Surveys Shows potential discrimination based on geography which may be a proxy for socio-economic status.

Non-discrimination
Indicator #30 (novel) The breast unit includes ASCO recommended integrative therapies to reduce stress, anxiety and depression: music therapy, meditation, stress management, yoga, relaxation, and massage Surveys A rights-based approach means that the physical and emotional wellbeing of the patient is taken into account, as opposed to a pure biomedical approach. The efficacy of these therapies were reviewed by the International Society of Oncologists from 1990 to 2015 and further approved by ASCO. They contribute to the AAAQ of services under the right to health and dignity of the person.
Availability, accessibility, acceptability and quality of health services Indicator #30 disaggregated (novel) Disaggregated by geography Surveys Shows potential discrimination based on geography which may be a proxy for socio-economic status.

Non-discrimination
Indicator #31 (novel) The breast unit includes ASCO recommended integrative therapies to reduce chemotherapy-induced nausea and vomiting: acupuncture and acupressure Surveys Same as above. Availability, accessibility, acceptability and quality of health services Indicator #31 disaggregated (novel) Disaggregated by geography Surveys Same as above. Non-discrimination Indicator #32 (novel) There is a referral system in place from the breast unit to psychological care Surveys A referral system ensures that the patient can access the service in a timely manner while triaging patients to avoid the service to be overloaded. This contributes to the AAAQ of psychological services for breast cancer patients.
Cost-effectiveness and availability, accessibility, acceptability and quality of health services Indicator #32 disaggregated (novel) Disaggregated by geography Surveys Shows potential discrimination based on geography which may be a proxy for socio-economic status.

Building blocks and indicators
Data sources How it contributes to realising the right to health Principles of the right to health There is a referral system in place from the breast unit to reconstructive surgery Surveys A referral system ensures that the patient can access the service in a timely manner while triaging patients to avoid the service to be overloaded. This contributes to the AAAQ of reconstructive services for breast cancer patients.
Availability, accessibility, acceptability and quality of health services Disaggregated by geography Surveys Shows potential discrimination based on geography which may be a proxy for socio-economic status.

Non-discrimination
There is a trained member of staff acting as patient navigator in the breast unit Surveys A trained navigator helps patients navigate between the range of services needed throughout the cancer journey, which may be extremely large and varied. It avoids unnecessary delays and may refrain patients from abandoning their treatment.
Acceptability and quality of health services Disaggregated by geography Surveys Shows potential discrimination based on geography which may be a proxy for socio-economic status. Non-discrimination

Data sources
How it contributes to realising the right to health Principles of the right to health Disaggregated by wealth quintile and ethnicity Not yet available at the international level This would show potential discrimination on the basis of socio-economic status and ethnicity.

Non-discrimination
Proportion of women with strong familial history of breast cancer who have had a mammography or MRI in the last 24 months Surveys This shows whether the state's commitment to breast cancer screening in women at higher risk is implemented in practice.
Cost-effectiveness, core obligations, availability and accessibility of health services Disaggregated by wealth quintile and ethnicity Surveys This would show potential discrimination on the basis of socio-economic status and ethnicity.

Non-discrimination
Proportion of women with advanced stage (IIB-IV) at diagnosis Hospital data, or ideally population-based cancer registry data This shows whether the state's commitment to early diagnosis is implemented in practice.
Cost-effectiveness, core obligations, availability and accessibility of diagnostic services Disaggregated by wealth quintile and ethnicity Hospital data, or ideally population-based cancer registry data This would show potential discrimination on the basis of socio-economic status and ethnicity.

Non-discrimination
Proportion of women with advanced breast cancer (stage IV) at diagnosis Hospital data, or ideally population-based cancer registry data This shows whether the state's commitment to early diagnosis is implemented in practice.
Cost-effectiveness, core obligations, availability and accessibility of diagnostic services Disaggregated by wealth quintile and ethnicity Hospital data, or ideally population-based cancer registry data This would show potential discrimination on the basis of socio-economic status and ethnicity. Non-discrimination

Non-discrimination
Proportion of breast cancer patients who were followed by one or more of the following during their treatment: a psychologist, a social worker, a dietitian, an exercise physiologist, a genetic counsellor, an occupational therapist, a physiotherapist, and a specialist palliative care.
Hospital data or Surveys This shows whether the state's commitment to treat breast cancer with multidisciplinary teams and to provide integrated care is applied in practice.
Acceptability and quality of health services Disaggregated by wealth quintile and ethnicity Hospital data or Surveys This would show potential discrimination on the basis of socio-economic status and ethnicity.

Non-discrimination
Proportion of breast cancer patients who received integrative therapies to help manage stress, anxiety and depression such as music therapy, meditation, stress management, yoga, relaxation, and massage Hospital data or Surveys This shows whether the state's commitment to provide integrated care is applied in practice.
Acceptability and quality of health services The state has a social health insurance system OECD HAG 2019 Shows the state's commitment as a primary duty bearer of the right to health. Indicates the financial accessibility of health services and care.
Cost-effectiveness, financial accessibility of health services The social health insurance system covers diagnostic services for breast cancer (i.e., biopsy, mammogram and ultrasound) Ministry of Health websites, national health system Indicates the financial accessibility of diagnostic services. Financial accessibility of diagnostic services The social health insurance system covers breast cancer treatment (i.e., hormone therapy and chemotherapy) Ministry of Health websites, national health system Indicates the financial accessibility of treatment. Financial accessibility of treatment The social health insurance system covers radiotherapy for breast cancer Ministry of Health websites, national health system Indicates the financial accessibility of treatment. Financial accessibility of treatment

Non-discrimination
The Constitution, Bill of Rights or other statute recognises the right to access essential medicines WHO report 2008 https://www.who.int/medicines/areas/human_rights/Perehudoff_repor t_constitutions_2008.pdf Indicates the formal recognition of the right to health and access to essential medicines.

Legal recognition
There is an official national medicines policy to provide access to essential medicines WHO, E-DRUG, Lancet Commission report (2016) Indicates the state's commitment to access to essential medicines. Indicates the state's commitment to epidemiological research, which is an obligation under para 43(f) of General Comment 14 (to adopt and implement a national public health strategy and plan of action, on the basis of epidemiological evidence, addressing the health concerns of the whole population).

Core obligations
The state law requires cancer registration IARC's cancer incidence in five continents Indicates the state's commitment to availability of health data for cancer to inform epidemiological research and monitor the effect of health policies.

Core obligations
The state law requires informed consent to treatment and other health interventions WHO genomics website in the first instance: http://www.who.int/genomics/public/patientrights/en/index.html or International Health Digest: http://www.who.int/idhlrils/frame.cfm?language=english Indicates the state's commitment to acceptability of health services by upholding the right to informed consent for treatment and other health interventions.

Acceptability of health services
The NCP or NCDP plans for cancer research, independent from pharmaceutical companies National cancer plans, non-communicable diseases plans Indicates the state's commitment to epidemiological research, which is an obligation under para 43(f) of General Comment 14 (to adopt and implement a national public health strategy and plan of action, on the basis of epidemiological evidence, addressing the health concerns of the whole population).

Core obligations
The NCP or NCDP protects the right to seek and receive health information National cancer plans, non-communicable diseases plans Indicates the state's commitment to protect the right to health information and the commitment to accessibility of health services by providing access to information.

Accessibility (information) of health services, core obligations
The NCP or NCDP addresses communication of information throughout the pathway of care for breast cancer, from screening through to referral, diagnosis, treatment options and palliative care National cancer plans, non-communicable diseases plans Indicates the state's commitment to access health information. Indicator based on ESMO recommendation. This indicator may be in the form of a score, the number corresponding to the items being covered by the communication of information (screening, referral, diagnosis, treatment, palliative care).

Informational accessibility of health services
The NCP or NCDP addresses the needs of patients from culturally and linguistically diverse backgrounds National cancer plans, non-communicable diseases plans Indicates the state's commitment to non-discriminatory access to health care and services.

Acceptability of heath services, nondiscrimination
The NCP or NCDP addresses participation of patients in decisions that affect them National cancer plans, non-communicable diseases plans Indicates the state's commitment to participation of patients, which is a requirement under the right to health.

Building blocks and indicators
Data sources How it contributes to realising the right to health Principles of the right to health The NCP or NCDP addresses awareness of breast self-examination National cancer plans, non-communicable diseases plans Indicates the state's commitment to cost-effectiveness of health policies, which is a requirement under para 44(c) of General Comment 14 (to take measures to prevent, treat and control epidemic and endemic diseases) and (d) (to provide education and access to information concerning the main health problems in the community, including methods of preventing and controlling them).

Cost-effectiveness, accessibility (information) of diagnostic services, core obligations
There is a charter of breast cancer patients' rights freely available and accessible to everyone National cancer patients associations and Europa Donna: https://www.europadonna.org/ Indicates the state's commitment to the right to health information, which is an obligation under para 44(d) of General Comment 14 (see above.) Accessibility (information) of health services, core obligations There is a national campaign to raise awareness about the screening programme Ministry of Health websites Shows availability of information about the screening programme. Accessibility (information) of health services, core obligations The screening programme is implemented through community outreach activities Ministry of Health websites, breast cancer patient associations Shows availability and accessibility of information about the screening programme.
Accessibility (information) of health services, core obligations The screening programme includes information on the potential disadvantages and benefits of mammographic screening Ministry of Health websites Shows the availability and quality of information about the screening programme.

Accessibility (information) of health services, core obligations
There is a national strategy to raise awareness on breast self-examination Ministry of Health websites Shows availability of information about breast self-examination, which is a key and cost-effective practice to detect early suspicions of breast cancer.

Accessibility (information) of health services
There is a national breast cancer patients association independent from the pharmaceutical industry Europa Donna database, Ministry of Health links to patients associations Shows the availability of patient support, including information delivered in an accessible way.

Accessibility (information) of health services
The personnel in the breast unit are trained to communicate information on diagnosis and treatment options, including side effects and survival, repeatedly, verbally and in writing, in a comprehensive and easily understandable form to patients Surveys Shows the accessibility and quality of information. This indicator is worded as per the ESMO guidelines.

Accessibility (information) and quality of health services
The personnel in the breast unit presents all options available to the patient beside a mastectomy, and explains in an easily understandable way psychological distress that may be associated with a mastectomy Surveys Shows the accessibility, acceptability and quality of information delivered to the patient so that she can make informed choices regarding their mastectomy.
Accessibility, acceptability and quality of health information, core obligations The personnel in the breast unit discusses breast reconstruction techniques individually taking into account anatomic, treatment-and patient-related factors and preferences Surveys Shows the availability, accessibility, acceptability and quality of information around breast reconstruction. Indicators worded as per ESMO guidelines.
Accessibility, acceptability and quality of health information, core obligations The breast unit website or other official source of information includes fertility issues and fertility-preservation techniques Internet search on a sample of hospitals Shows the availability, accessibility, acceptability and quality of information around fertility issues due to chemotherapy. Indicators worded as per ESMO guidelines.
Accessibility, acceptability and quality of health information, core obligations The breast cancer unit uses trained interpreters when communicating with patients from culturally and linguistically diverse background Surveys Shows the availability, accessibility, acceptability and quality of communication of information to breast cancer patients.
Accessibility, acceptability and quality of health information, core obligations The breast unit has a participatory process in place to include patients into decisions that affect them individually Surveys Shows the availability of a participatory mechanism for breast cancer patients. Participation The breast unit directs patients to reliable, patient-centred websites Surveys Shows the availability, accessibility, acceptability and quality of information delivered to breast cancer patients.
Accessibility, acceptability and quality of health information, core obligations There is a state funded cancer registry Online search and governments' websites Shows the availability of health data to inform epidemiological research and monitor the effect of health policies.
Availability of epidemiological data, core obligations

Building blocks and indicators
Data sources How it contributes to realising the right to health Principles of the right to health The NCP or NCDP includes a protection against discrimination National cancer plans, non-communicable diseases plans Indicates the state's commitment against discrimination in relation to cancer care and control specifically.

Non-discrimination
The NCP or NCDP includes an explicit commitment to universal access to cancer services and treatment National cancer plans, non-communicable diseases plans This indicates the state's core obligation of the right to health listed at paragraph 43(a) of General Comment 14 (to ensure the right of access to health facilities, goods and services on a non-discriminatory basis, especially for vulnerable or marginalized groups).
Non-discrimination, core obligations The NCP or NCDP includes a set of targets and progress indicators specific to breast cancer National cancer plans, non-communicable diseases plans Targets and indicators are necessary to measure progress towards the realisation of the right to health. This is a key tool for the "progressive realisation" element of the right to health. Monitoring is also a core obligation listed at paragraph 43(f) of General Comment 14 (the strategy and plan of action shall be devised, and periodically reviewed, on the basis of a participatory and transparent process; they shall include methods, such as right to health indicators and benchmarks, by which progress can be closely monitored).

Core obligations
The state undertook a health impact assessment before adopting the national cancer plan National cancer plans, non-communicable diseases plans This indicates the state's core obligation of the right to health listed at paragraph 43(f) of General Comment 14 (to adopt and implement a national public health strategy and plan of action, on the basis of epidemiological evidence, addressing the health concerns of the whole population).

Core obligations
The health impact assessment explicitly included the right to health National cancer plans, non-communicable diseases plans Indicates the state's commitment to realise the right to health.

Legal recognition
The NCP or NCDP includes a requirement for the participation of marginalised groups National cancer plans, non-communicable diseases plans Participation of affected groups is a key principle of the right to health. It is also necessary to realise the core obligation listed at paragraph 43(a) of General Comment 14 (to ensure the right of access to health facilities, goods and services on a non-discriminatory basis, especially for vulnerable or marginalized groups) and paragraph 43 (f) (the process by which the strategy and plan of action are devised, as well as their content, shall give particular attention to all vulnerable or marginalized groups).

Building blocks and indicators
Data sources How it contributes to realising the right to health Principles of the right to health The state has an operational policy, strategy or action plan to reduce the burden of tobacco use Government's websites Indicates the state's commitment to the right to health, and commitment to tackle the underlying determinants of health. The state also has a core obligation to adopt a national plan or strategy to address the health concerns of the population (para 43(f) of General Comment 14) and to prevent, treat and control endemic and epidemic diseases (paragraph 44(c)).

Prevention (core obligation)
The state has an operational policy, strategy or action plan to reduce overweight and obesity Government's websites Same as above. Prevention (core obligation) The state has an operational policy, strategy or action plan to reduce physical inactivity and/or promote physical activity Government's websites Same as above.
Prevention (core obligation) The state has an operational policy, strategy or action plan to reduce the harmful use of alcohol Government's websites Same as above.
Prevention (core obligation) The country air pollution is below the WHO recommended annual mean (10 μg/m3 for fine particulate matter PM2.5 and 20 μg/m3 for coarse particulate matter PM10) Global Health Observatory: https://www.who.int/data/gho/data/indicators/indicatordetails/GHO/concentrations-of-fine-particulate-matter-(pm2-5) Indicates a key outcome on the underlying determinants of health. Prevention (core obligation) There is an accessible pre-judicial mechanism to lodge complaints alleging breach of obligations connected to the right to health Google search Indicates the state's commitment to provide redress for victims, to enforce the right to health, and to ensure accountability of wrongdoers and health institutions.

Accountability
Number of court cases litigated on cancer in a given year Global Health and Human Rights database (category is NCDs, not cancer specifically): https://www.globalhealthrights.org/ Indicates both the level of access to justice and the issues in the realisation of the right to health for cancer patients specifically. The caveat is that only a few wealthy individuals may have access to litigation in practice, so the court cases would not be representative of poorer or marginalised individuals.

Accountability
Proportion of class actions among the cases litigated on cancer in a given year Manual search in Global Health and Human Rights database Indicates the level of access to justice and systemic issues in the realisation of the right to health for cancer patients. Class actions may be more representative of the population and systemic issues as it is brought by a group of affected individuals, as opposed to one person. The outcome of the litigation may also be fairer at a group level, rather than creating inequalities between those who could access litigation and those who could not in individual cases.

Accountability
The breast unit has a formal complaints mechanism for patients Surveys Indicates the access to justice for breast cancer patients at the hospital level. This may be more meaningful and accessible for patients than litigation in court.

Accountability
Disaggregated by geography Surveys Shows potential discrimination based on geography which may be a proxy for socio-economic status.

Building blocks and indicators
Data sources How it contributes to realising the right to health Principles of the right to health Proportion of the population at risk participating in the screening programme National health statistics Cancer screening allows early detection of breast cancer, which in turn is associated with better chances of survival.
Cost-effectiveness, core obligations Prevalence of certified nurses per 1,000,000 population OECD data Indicates availability of health personnel. Availability of health workforce The State has ratified key human rights treaties recognising the right to health OHCHR website Indicates whether the state is committed to the right to health as protected by international human rights law.

End of document
Words in italic and underlined show reformulation as per the panel's suggestions.